GDP in the Aviation and Marine sectors

Schedule 17

Regulatory Requirements: The Human Medicines Regulations 2012 mandate that licence holders and responsible persons establish robust procedures for verifying the authority and legitimacy of customers receiving medicinal products.

Customer Qualification:  While qualifying hospitals and pharmacies is straightforward, it becomes more complex for airborne or aquatic customers (e.g., aircraft, fishing vessels, oil platforms).

Exemptions under Schedule: Schedule 17 outlines specific exemptions from restrictions on the sale and supply of certain medicinal products but does not allow unrestricted access to all medicines.

Documentation and Traceability: Companies must fully document the qualification process within their Quality Management System to ensure traceability back to the person placing the order.

Validation of Authority: It's essential to validate the authority of the individual (e.g., commander of an aircraft or master of a vessel) before supplying medicines. Orders should match between the commander and the company placing the order on their behalf.

Medical Kit Regulations: Aircraft must have a suitably approved medical kit onboard before flight, as specified by UK Regulation (EU) No. 965/2012.

Marine Sector Compliance: Organizations in the marine sector should ensure compliance with legal requirements related to vessels and ports before dispatching medicinal products.

Delivery

Qualified Personnel and Order: After qualifying the commander or master and receiving a matching order, the journey may still be complex.

Delivery Compliance: According to Chapter 9 of GDP, deliveries must go to the specified address and cannot be left at alternative locations.

Challenges in Access: Deliveries to marine and aviation customers face challenges due to restricted access to docks and airports.

MHRA Guidelines: The MHRA allows delivery to goods inwards facilities but requires clear documentation for timely delivery.

Just in Time" Delivery: Orders should not be stored long in port or airport facilities to avoid licensing issues.

GDP Compliance: Organisations should ensure compliance with GDP guidance and conduct regular risk assessments.

Qualifying Facilities: Considerations for ports/airports include security measures, hours of operation, and receiving area locations.

Requalification Requirement: Qualifying the aircraft or vessel for one location does not mean it's qualified for all; the process must be repeated for each new port or airport.

Altered and Repackaged Medicines

- A wholesale dealer licence (WDA) is needed for supplying medicines and first-aid kits to aircraft and vessels.

- The kits must only contain human medicines with a UK marketing authorisation (MA) that have not been altered and comply with the MA presentation.

- If changes to the presentation or packaging of the licensed medicine are necessary, a manufacturer's licence (MIA) is required, which must include a Qualified Person (QP).

- The QP has ongoing responsibilities for batch certification under the manufacturer's licence.

- Any changes, including licensed assembler, new pack size, and presentation, must be reflected in the relevant product's marketing authorisation.

Export

Customer Qualification: Ensure that the customer is fully qualified before proceeding with the order.

Order Process: Have a reliable process in place to ensure that the order arrives at the port coinciding with the vessel's arrival.

Documentation: Make sure that the loading of the order is fully documented.

Flag of Vessel: The nationality of the vessel (flag) can present potential issues, particularly regarding export requirements.

Export License: If the vessel is not British flagged, an export license and the relevant export declarations are necessary, even if the vessel is docked in a UK port.

Foreign Commercial Aircraft: All foreign commercial aircraft operating to the UK must possess a CAA Foreign Carrier Permit.

Recalls

Annual Assessment: Companies must conduct annual assessments of their recall systems to ensure preparedness.

Challenges in Aviation and Marine Sectors: Unique challenges arise in these sectors regarding contact and retrieval of affected stock.

Efficient Recall Planning: It is essential for companies to strategize and develop efficient recall procedures in anticipation of potential issues.

Unusual sales pattern monitoring

Careful Consideration: Organisations must assess the volumes and types of medicines being supplied.

Monitor Requests: Remain vigilant for any unusual requests that could indicate diversion.

Reporting Suspicion: If diversion is suspected, report it to The Bureau at the specified email.